Open, ClassifiedPosted Jul 29, 2025·Initiated Jun 27, 2025
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Reason: Device does not comply with the labeling requirements of international standard IEC 60601-1.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiopulmonary GmbhType: Accessory Equipment, Cardiopulmonary BypassDistribution: Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.Recall #Z-2193-2025
Open, ClassifiedPosted Jul 29, 2025·Initiated Jun 27, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Reason: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.Recall #Z-2194-2025
Open, ClassifiedPosted Jul 29, 2025·Initiated Jun 27, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Reason: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.Recall #Z-2195-2025
Open, ClassifiedPosted Jul 29, 2025·Initiated May 22, 2025
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Reason: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Root cause: Under Investigation by firm
Recalling firm: LTS Therapy Systems, LLCType: Device, Iontophoresis, Other UsesDistribution: US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.Recall #Z-2196-2025
Open, ClassifiedPosted Jul 29, 2025·Initiated May 22, 2025
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080;
The IontoPatch is an Iontophoresis transdermal patch.
Reason: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Root cause: Under Investigation by firm
Recalling firm: LTS Therapy Systems, LLCType: Device, Iontophoresis, Other UsesDistribution: US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.Recall #Z-2197-2025
Open, ClassifiedPosted Jul 29, 2025·Initiated Apr 21, 2025
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Reason: Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
Root cause: Device Design
Recalling firm: Capnia IncType: Analyzer, Gas, Carbon-Monoxide, Gaseous-PhaseDistribution: US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.Recall #Z-2198-2025
Open, ClassifiedPosted Jul 28, 2025·Initiated May 29, 2025
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Reason: Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
Root cause: Device Design
Recalling firm: MICROVENTION INC.Type: Device, Vascular, For Promoting EmbolizationDistribution: OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russian Federation, Kuwait, Republic of North Macedonia, Switzerland, Saudi Arabia, Georgia, Lithuania, Romania, Croatia, Chile, Hong Kong , India, Mexico, Taiwan, VietnamRecall #Z-2188-2025
Open, ClassifiedPosted Jul 26, 2025·Initiated Jun 23, 2025
Automated Impella Controller (AIC), used in left heart support blood pump, including the following:
1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU.
2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.
4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L.
5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN.
6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP.
7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L.
8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.
9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.
10. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L.
12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU.
13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.
14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L.
15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN.
16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.
17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L.
18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L.
20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU.
21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA.
22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L.
23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU.
24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L.
25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP.
26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L.
27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK.
28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L.
30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201.
31. AIC w/Impella Connect for ECP; Product Code: 1000432.
Reason: A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Root cause: Device Design
Open, ClassifiedPosted Jul 25, 2025·Initiated May 1, 2025
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills.
Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short 6-13mm depth, and Long 6-16mm depth), and in several diameters for different diameter drills.
Reason: The Drill stop kit contains incorrect components.
Root cause: Under Investigation by firm
Recalling firm: Implant Direct Sybron Manufacturing LLCType: Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ, NV, NY, OH, OK, TN, TX, UT, VA and the country of Japan.Recall #Z-2172-2025
Open, ClassifiedPosted Jul 25, 2025·Initiated Jun 30, 2025
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P
The HeartSine samaritan PAD (Public Access Defibrillator)
Reason: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Root cause: Process change control
Recalling firm: HeartSine Technologies LtdType: Automated External Defibrillators (Non-Wearable)Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Indonesia, Ireland, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Singapore, South Korea, Taiwan, Thailand, and United Kingdom.Recall #Z-2174-2025
Open, ClassifiedPosted Jul 25, 2025·Initiated May 30, 2025
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Reason: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Root cause: Software change control
Recalling firm: Remote Diagnostic Technologies Ltd.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.Recall #Z-2175-2025
Open, ClassifiedPosted Jul 25, 2025·Initiated Jun 23, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Reason: The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
Root cause: Process control
Recalling firm: Steris CorporationType: Light, Surgical, Ceiling MountedDistribution: Worldwide - US Nationwide and Puerto Rico and the country of Canada.Recall #Z-2177-2025 Open, ClassifiedPosted Jul 25, 2025·Initiated Jun 23, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Reason: The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
Root cause: Process control
Recalling firm: Steris CorporationType: Light, Surgical, Ceiling MountedDistribution: Worldwide - US Nationwide and Puerto Rico and the country of Canada.Recall #Z-2178-2025 Open, ClassifiedPosted Jul 23, 2025·Initiated Feb 7, 2025
Bodor's I series laser cutting machine.
Reason: The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Jinan Bodor Cnc Machine Co LtdType: Laser CutterDistribution: USRecall #Z-2149-2025
Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 23, 2025
BD COR System Software. Model Number: 444829.
Reason: Potential for functionality issue that supports the Over
labeling feature and could lead to possible false negative results.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Kit, Dna Detection, Human PapillomavirusDistribution: Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.Recall #Z-2162-2025
Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 12, 2025
ACUVUE OASYS MAX 1-Day MULTIFOCAL
Reason: Due to defects (bubbles/voids) identified during standard finished goods testing
Root cause: Nonconforming Material/Component
Recalling firm: Johnson & Johnson Vision Care, Inc.Type: Lenses, Soft Contact, Daily WearDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.Recall #Z-2163-2025
Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 16, 2025
Biofinity XR Toric Contact Lens
Reason: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Root cause: Use error
Recalling firm: CooperVision, Inc.Type: Lenses, Soft Contact, Extended WearDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.Recall #Z-2165-2025
Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 16, 2025
Biofinity Toric Multifocal Contact Lens
Reason: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Root cause: Use error
Recalling firm: CooperVision, Inc.Type: Lenses, Soft Contact, Extended WearDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.Recall #Z-2166-2025
Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 18, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components:
1. Cobalt Crome application, Software Model Number D00U005;
2. Claria Amplia Compia application, Software Model Number D00U009;
3. Evera MRI application, Software Model Number D00U010;
3. Visia AF application, Software Model Number D00U011;
5. Viva Brava Evera application, Software Model Number D00U012;
Reason: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Root cause: Software design
Recalling firm: Medtronic, Inc.Type: Pulse Generator, Permanent, ImplantableDistribution: Worldwide - US Nationwide distribution.Recall #Z-2168-2025 Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 18, 2025
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components:
1. Cobalt Crome application, Software Model Number D00U005;
2. Claria Amplia Compia application, Software Model Number D00U009;
3. Evera MRI application, Software Model Number D00U010;
3. Visia AF application, Software Model Number D00U011;
5. Viva Brava Evera application, Software Model Number D00U012;
Reason: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Root cause: Software design
Recalling firm: Medtronic, Inc.Type: Pulse Generator, Permanent, ImplantableDistribution: Worldwide - US Nationwide distribution.Recall #Z-2169-2025